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Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients

NCT04301362 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2020-03-12

No results posted yet for this study

Summary

The main venous thromboembolism (VTE) risk prediction model for ambulatory cancer patients is Khorana. Cancer thrombosis is associated with elevated thrombin generation. Its quantification is a promising method for evaluating patient's thrombotic profile.

This study aims to develop a predictive model of VTE risk in ambulatory cancer patients, combining thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score.

This is a prospective observational study that includes newly diagnosed cancer patients proposed for anti-tumor treatment (chemotherapy, immunotherapy or targeted therapies). Patients with disease progression are allowed if chemotherapy-free for 3 months. A 6-month mean incidence of VTE 6-10% is expected, requiring a sample size of 600 patients. Blood sample is collected at inclusion to analyze thrombosis biomarkers and blood count. The primary endpoint is the occurrence of symptomatic or incidental VTE within 6 months of inclusion. Models will follow a logistic approach with K-fold cross-validation (k=10). Model quality will be assessed with Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC). Decision for entering predictors in multivariate models will be based on p \<.10 in the univariate analysis.

Conditions

Interventions

DIAGNOSTIC_TEST

Thrombosis biomarkers

Blood samples shall be prepared according to the manufacturer's instructions and stored at -80°C until analysis. Thrombin generation will be measured using the commercial kit STG®-Tromboscreen kit (Stago). The D-dimers will be quantified using STA LIATEST® D-DI PLUS (Stago).

Sponsors & Collaborators

  • LEO Pharma

    collaborator INDUSTRY

  • Diagnostica Stago

    collaborator INDUSTRY

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    lead OTHER_GOV

Principal Investigators

  • David Ferreira, MD · Centro Hospitalar Vila Nova de Gaia/Espinho

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2021-07-19
Completion
2021-12-19

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301362 on ClinicalTrials.gov